Squamous Cell Carcinoma of the Penis, Usual TypePhase 3InPACTNCT02305654

International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)

A Phase 3 study testing ILND - Inguinal Lymph Node Dissection, Paclitaxel and Ifosfamide in people with Squamous Cell Carcinoma of the Penis, Usual Type, run by Institute of Cancer Research, United Kingdom at 17 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Squamous Cell Carcinoma of the Penis, Usual Type
What is being tested?: ILND - Inguinal Lymph Node Dissection, Paclitaxel and Ifosfamide
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 17 sitesin 2 countries
Study dates: 12 May 2017to 30 Nov 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent
Measurable disease as determined by RECIST (version 1.1) criteria;
Histologically-proven squamous cell carcinoma of the penis,
Stage:
any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0 or;
any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes), M0 or;
any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0
Performance Status ECOG 0, 1 or 2.

Who cannot join

Pure verrucous carcinoma of the penis,
Nonsquamous malignancy of the penis,
Squamous carcinoma of the urethra,
Stage M1,
Previous chemotherapy or chemoradiotherapy,
Concurrent malignancy (other than SCC or Basal Cell Carcinoma of non-penile skin) that has required surgical or non-surgical treatment in the last 3 years.

Trial locations and contacts

17 sites in 2 countries.

Country

City, postcode or hospital

17 sites in 2 countries

United States11 sites

Grady Health System
Atlanta, Georgia, 30303
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Los Angeles County-USC Medical Center
Los Angeles, California, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Mayo Clinic
Rochester, Minnesota, 55905
Moffitt Cancer Center
Tampa, Florida, 33612

Other trials in United States

United Kingdom6 sites

Velindre NHS Trust
Cardiff, CF14 2TL
University Hospitals of Leicester NHS Trust
Leicester, LE1 5WW
The Royal Marsden NHS Foundation Trust
London, SM2 5PT
St George's Hospital NHS Foundation Trust
London, SW17 0QT
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, NR4 7UY
Swansea Bay University Health Board
Swansea, SA6 6NL

Other trials in United Kingdom

About this study

This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable potential randomisation for the majority of patients with inguinal lymph node metastases and will provide data to inform future clinical decisions.

InPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological criteria. Treatment options are then defined according to the disease burden strata. Treatment is allocated by randomisation. Patients may be allocated to one of three initial treatments:

standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND); or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND).

After ILND, patients are defined as being at low or high risk of recurrence based on histological interpretation of the ILND specimen. Patients at high risk of relapse are eligible for InPACT-pelvis, where they are randomised to either:

prophylactic PLND Q. no prophylactic PLND

Conditions: Squamous Cell Carcinoma of the Penis, Usual Type
Being tested: ILND - Inguinal Lymph Node Dissection, Paclitaxel, Ifosfamide, Cisplatin, Intensity modulated radiation treatment (IMRT)
Keywords: Penis cancer, Chemotherapy, Chemoradiotherapy, Surgery, Phase III
Medical subject headings: Penile Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ILND - Inguinal Lymph Node DissectionProcedure or surgery
Surgery to remove the lymph nodes in the groin near to where the cancer first appeared.
PaclitaxelDrug
Also called Taxol
Dose 175mg/m2 as part of TIP regimen.
IfosfamideDrug
Also called Mitoxana
Dose 900mg/m2 as part of TIP regimen.
CisplatinDrug
Dose 15mg/m2 as part of TIP regimen (neoadjuvant chemotherapy arm) Dose 40mg/m2 for use concurrently with raditotherapy (chemoradiotherapy arm)
Intensity modulated radiation treatment (IMRT)Radiation
Treatment with very high energy X-rays (radiotherapy).
Prophylactic PLND - pelvic lymph node dissectionProcedure or surgery
Surgery to remove the lymph nodes deeper in the pelvis, further away from where the cancer first appeared, that are at high risk of harbouring cancer.

Study groups in NCT02305654
Study group	Role	What they receive
Arm A - Standard Surgery (ILND)	Active comparator	Part of randomisation 1. The total treatment duration (Inguinal Lymph Node Dissection (ILND)) is estimated to be over 1 day for those patients allocated to Arm A - standard surgery. Receives: Procedure: ILND - Inguinal Lymph Node Dissection
Arm B - neoadjuvant chemotherapy	Experimental	Part of randomisation 1. Patients will receive up to 4 cycles of Paclitaxel, Ifosfamide, and Cisplatin (TIP). Administration on an outpatient basis: Paclitaxel 175 mg/m2, day 1, Ifosfamide 900 mg/m2, days 2-5, Cisplatin 15 mg/m2, days 1-5 Administration on an inpatient basis: Paclitaxel 175 mg/m2, day 1, Ifosfamide 1200 mg/m2, days 1-3, Cisplatin 25 mg/m2, days 1-3 Receives: Drug: Paclitaxel; Drug: Ifosfamide; Drug: Cisplatin
Arm C - neoadjuvant chemoradiotherapy	Experimental	Part of randomisation 1. Radiotherapy dose is 45Gy in 25 fractions over 5 weeks using 6-10 MV photons to all regions. Concurrent cisplatin 40mg/m2 will be given weekly, subject to GFR>45mls/min. Receives: Drug: Cisplatin; Radiation: Intensity modulated radiation treatment (IMRT)
Arm P - prophylactic PLND	Experimental	Part of randomisation 2. Prophylactic pelvic lymph node dissection (PLND) - The total treatment duration is estimated to be over 1 day. Patients who have NOT received neoadjuvant chemoradiotherapy will receive adjuvant chemoradiotherapy: Cisplatin 40mg/m2 will be given weekly, subject to GFR>45mls/min. Groin: One or both groins may be boosted up to 54Gy in 25 fractions. An IMRT boost of up to 57 Gy can be given to recurrent or residual macroscopic tumour Pelvis: the dose is limited to 45Gy unless IMRT is available. An IMRT boost of up to 54Gy in 25 fractions is applied to: 1. Any macroscopic tumour or pathological lymph nodes 2. Electively to external iliac nodes in patient with high disease burden Patients who have had neoadjuvant chemoradiotherapy will have prophylactic PLND alone. Receives: Procedure: Prophylactic PLND - pelvic lymph node dissection
Arm Q - Surveillance no prophylactic PLND	No intervention	no prophylactic PLND Part of randomisation 2. For patients who have NOT received neoadjuvant chemoradiotherapy: Groin: One or both groins may be boosted up to 54Gy in 25 fractions. An IMRT boost of up to 57 Gy can be given to recurrent or residual macroscopic tumour Pelvis: the dose is limited to 45Gy unless IMRT is available. An IMRT boost of up to 54Gy in 25 fractions is applied to: Any macroscopic tumour or pathological lymph nodes Electively to external iliac nodes in patient with high disease burden

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall survival
The primary outcome measure that will be measured for all trial patients is survival time. This is defined in whole days as the time from the date of randomisation to the date of death from any cause; for those who have not been reported as dead at the time of analysis, the survival time will be censored at the date of last follow-up.
Measured: up to 5 years

Secondary outcomes (10)

Disease specific survival time
Disease-specific survival time which is defined in whole days as the time from the date of randomisation to the date of death specifically from disease; for those who have not been reported as dead at the time of analysis, the survival time will be censored at the date of last follow-up and for those whose death is reported as non-disease specific then the survival time will be censored at date of death.
Measured: up to 5 years
Number of patients experience a grade 3 or 4 toxicity
Measured: up to 5 years
Disease-free survival time
Disease-free survival time (DFST) which is defined in whole days as the time from date of randomisation to the date of either locoregional recurrence, distant metastasis or death from disease, whichever occurs first; for those who have not been reported as experiencing any of these events, the DFST will be censored at the date last known to be alive and free of disease or date of non-disease-specific death. A supplementary exploratory outcome measure will also be calculated taking date of penectomy as the origin rather than date of randomisation.
Subsidiary outcome measures will be
- locoregional recurrence free survival time (LRFST).
- distant metastases free survival time (DMFST).
- A supplementary exploratory outcome measure will also be calculated taking date of penectomy as the origin for all these outcome measures rather than date of randomisation.
Measured: up to 5 years
Occurrence of surgical complication
Measured: up to 5 years
Is it possible to achieve pathological nodal assessment after chemotherapy
Feasibility of pathological nodal assessment after chemotherapy which is recorded as whether or not it was possible to achieve a pathological nodal assessment after chemotherapy.
Measured: 12 weeks
Quality of life
Measured using the EORTC-QLQC30 and Lymphodema-QL
Measured: Baseline, 3, 6, 9, 12, 18, 24 and 36 months
Occurrence of Pathological complete remission
Measured for all patients in InPACT-neoadjuvant:
Absolute absence of disease on histological examination
Measured: Time to complete remission after randomisation
Operability
Measured for all trial patients in InPACT-neoadjuvant. Operability which will be recorded as whether or not the planned inguinal node dissection was undertaken and the reasons if it did not occur.
Measured: 2-6 weeks
Occurrence of Lower limb/scrotal oedema
Occurrence of Lower limb/scrotal oedema which is recorded as whether or not the patient experiences a lower limb or scrotal oedema
Measured: up to 5 years
On-schedule delivery of neoadjuvant therapy
Feasibility of on-schedule delivery of neoadjuvant therapy
Measured: After randomisation up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 May 201730 Nov 2027

First posted2 Dec 2014 (estimated)
Study start12 May 2017
Primary completion31 May 2027 (estimated)
Study completion30 Nov 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Squamous Cell Carcinoma of the Penis, Usual TypeStudies of the same condition, open and under way.
More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02305654
Sponsor's protocol ID: ICR CTSU/2014/10048
Other IDs: CRUK/13/005, 13580965, EA8134, IRCI004, 2015-001199-23, 2015
Acronym: InPACT
Status last verified: Aug 2026
First submitted: 23 Sep 2014
Last updated: 31 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
ClinicalTrials.gov ID: NCT02305654
Acronym / sponsor ID: InPACT / ICR CTSU/2014/10048
Conditions: Squamous Cell Carcinoma of the Penis, Usual Type
Keywords: Penis cancer, Chemotherapy, Chemoradiotherapy, Surgery, Phase III
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 200 participants (estimated)
Lead sponsor: Institute of Cancer Research, United KingdomUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), ECOG-ACRIN Cancer Research Group
Study start: 12 May 2017 (actual)
Primary completion: 31 May 2027 (estimated)
Study completion: 30 Nov 2027 (estimated)
First posted: 2 Dec 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND); or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND).

prophylactic PLND Q. no prophylactic PLND

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Arm A - Standard Surgery (ILND)	Active comparator	Procedure: ILND - Inguinal Lymph Node DissectionPart of randomisation 1. The total treatment duration (Inguinal Lymph Node Dissection (ILND)) is estimated to be over 1 day for those patients allocated to Arm A - standard surgery.
Arm B - neoadjuvant chemotherapy	Experimental	Drug: Paclitaxel, Drug: Ifosfamide, Drug: CisplatinPart of randomisation 1. Patients will receive up to 4 cycles of Paclitaxel, Ifosfamide, and Cisplatin (TIP). Administration on an outpatient basis: Paclitaxel 175 mg/m2, day 1, Ifosfamide 900 mg/m2, days 2-5, Cisplatin 15 mg/m2, days 1-5 Administration on an inpatient basis: Paclitaxel 175 mg/m2, day 1, Ifosfamide 1200 mg/m2, days 1-3, Cisplatin 25 mg/m2, days 1-3
Arm C - neoadjuvant chemoradiotherapy	Experimental	Drug: Cisplatin, Radiation: Intensity modulated radiation treatment (IMRT)Part of randomisation 1. Radiotherapy dose is 45Gy in 25 fractions over 5 weeks using 6-10 MV photons to all regions. Concurrent cisplatin 40mg/m2 will be given weekly, subject to GFR>45mls/min.
Arm P - prophylactic PLND	Experimental	Procedure: Prophylactic PLND - pelvic lymph node dissectionPart of randomisation 2. Prophylactic pelvic lymph node dissection (PLND) - The total treatment duration is estimated to be over 1 day. Patients who have NOT received neoadjuvant chemoradiotherapy will receive adjuvant chemoradiotherapy: Cisplatin 40mg/m2 will be given weekly, subject to GFR>45mls/min. Groin: One or both groins may be boosted up to 54Gy in 25 fractions. An IMRT boost of up to 57 Gy can be given to recurrent or residual macroscopic tumour Pelvis: the dose is limited to 45Gy unless IMRT is available. An IMRT boost of up to 54Gy in 25 fractions is applied to: 1. Any macroscopic tumour or pathological lymph nodes 2. Electively to external iliac nodes in patient with high disease burden Patients who have had neoadjuvant chemoradiotherapy will have prophylactic PLND alone.
Arm Q - Surveillance no prophylactic PLND	No intervention	–no prophylactic PLND Part of randomisation 2. For patients who have NOT received neoadjuvant chemoradiotherapy: Groin: One or both groins may be boosted up to 54Gy in 25 fractions. An IMRT boost of up to 57 Gy can be given to recurrent or residual macroscopic tumour Pelvis: the dose is limited to 45Gy unless IMRT is available. An IMRT boost of up to 54Gy in 25 fractions is applied to: Any macroscopic tumour or pathological lymph nodes Electively to external iliac nodes in patient with high disease burden

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Written informed consent
Measurable disease as determined by RECIST (version 1.1) criteria;
Histologically-proven squamous cell carcinoma of the penis,
Stage:
Performance Status ECOG 0, 1 or 2.

Key exclusion criteria (6 listed)

Pure verrucous carcinoma of the penis,
Nonsquamous malignancy of the penis,
Squamous carcinoma of the urethra,
Stage M1,
Previous chemotherapy or chemoradiotherapy,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ILND - Inguinal Lymph Node DissectionSurgery to remove the lymph nodes in the groin near to where the cancer first appeared.	Procedure or surgery	Arm A - Standard Surgery (ILND)
PaclitaxelAlso: TaxolDose 175mg/m2 as part of TIP regimen.	Drug	Arm B - neoadjuvant chemotherapy
IfosfamideAlso: MitoxanaDose 900mg/m2 as part of TIP regimen.	Drug	Arm B - neoadjuvant chemotherapy
CisplatinDose 15mg/m2 as part of TIP regimen (neoadjuvant chemotherapy arm) Dose 40mg/m2 for use concurrently with raditotherapy (chemoradiotherapy arm)	Drug	Arm B - neoadjuvant chemotherapy, Arm C - neoadjuvant chemoradiotherapy
Intensity modulated radiation treatment (IMRT)Treatment with very high energy X-rays (radiotherapy).	Radiation	Arm C - neoadjuvant chemoradiotherapy
Prophylactic PLND - pelvic lymph node dissectionSurgery to remove the lymph nodes deeper in the pelvis, further away from where the cancer first appeared, that are at high risk of harbouring cancer.	Procedure or surgery	Arm P - prophylactic PLND

Primary outcome

Overall survival
Time frame: up to 5 years
The primary outcome measure that will be measured for all trial patients is survival time. This is defined in whole days as the time from the date of randomisation to the date of death from any cause; for those who have not been reported as dead at the time of analysis, the survival time will be censored at the date of last follow-up.

10 secondary outcomes

Disease specific survival time
Time frame: up to 5 years
Number of patients experience a grade 3 or 4 toxicity
Time frame: up to 5 years
Disease-free survival time
Time frame: up to 5 years
Occurrence of surgical complication
Time frame: up to 5 years
Is it possible to achieve pathological nodal assessment after chemotherapy
Time frame: 12 weeks
Quality of life
Time frame: Baseline, 3, 6, 9, 12, 18, 24 and 36 months
Occurrence of Pathological complete remission
Time frame: Time to complete remission after randomisation
Operability
Time frame: 2-6 weeks
Occurrence of Lower limb/scrotal oedema
Time frame: up to 5 years
On-schedule delivery of neoadjuvant therapy
Time frame: After randomisation up to 12 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steve Nicholson study chair

Mid and South Essex NHS Foundation Trust

Curtis Pettaway study chair

University of Texas M.D. Anderson Cancer Center ; 713-792-3250 ; cpettawa@mdanderson.org

17 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02305654.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.